| CTRI Number |
CTRI/2024/06/069508 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Problem of Mass coming out of private parts in the women in community. |
|
Scientific Title of Study
|
Prevalence of Symptomatic pelvic organ prolapse in Belgavi district, India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajan R Patil |
| Designation |
Professor |
| Affiliation |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
| Address |
Department of Public Health JNMC, Nehru Nagar, Belagavi, Karnataka
Belgaum KARNATAKA 590010 India |
| Phone |
9445811610 |
| Fax |
|
| Email |
rajanpatil@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajandra Nerli |
| Designation |
Professor |
| Affiliation |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
| Address |
Department of Urology
Dr. Prabhakar Kore Hospital
JNMC, Neharu Nagar Belgaum Karnatak
Belgaum KARNATAKA 590010 India |
| Phone |
9353940487 |
| Fax |
|
| Email |
rajendranerli@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Rajan R Patil |
| Designation |
Professor |
| Affiliation |
J N Medical College, KLE Academy of Higher Education and Research, Belagavi |
| Address |
Department of Public Health JNMC, Nehru Nagar, Belagavi, Karnataka
Belgaum KARNATAKA 590010 India |
| Phone |
9445811610 |
| Fax |
|
| Email |
rajanpatil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| University internal seed money for Research by KLE Academy of Higher Education and Research,
Neharu nagar, Belagavi 560010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research Belagavi |
| Address |
Univesity Internal Seed money grant for research, KLE Academy of Higher Education and Research Nehru Nagar Belagavi, Karnataka 560010 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajan R Patil |
Dr. Prabhakar Kore Hosptial and Research Centre |
Room 21, Department of Urology, Ist floor, Dr. Prabakar Kore Hospital, NEHARU NAGAR, BELGAUM 560010 Belgaum KARNATAKA |
9445811610
rajanpatil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N819||Female genital prolapse, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
None |
None |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
All non-pregnant women at the age of 15, married women (past & present) above consenting to participate in the study |
|
| ExclusionCriteria |
| Details |
All pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of symptomatic pelvic organ prolapse |
At the time of evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urinary incontinence |
At the time of evaluation |
| Voiding dysfunction |
At the time of evaluation |
|
|
Target Sample Size
|
Total Sample Size="1500" Sample Size from India="1500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background Pelvic organ prolapse (POP) is defined as “the descent of one or more aspects of the vagina and the uterus: the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or the cuff scare after hysterectomy. Women with early onset POP are generally asymptomatic while women with advanced POP often experience a palpable bulge in the vagina along with concurrent lower urinary tract and anorectal dysfunction. However, POP significantly affects women’s quality of life when the bulging interferes with normal sexual, urinary, or bowel function. Prevalence of POP is estimated to be 15% in low and middle-income countries. Specific Aims: Prevalence of symptomatic pelvic organ prolapse in women residing in Belagavi, India Proportions of women who screen positive for prolapse associated pelvic floor dysfunction a. Lower urinary tract dysfunction (urinary incontinence, voiding dysfunction) b. Anorectal dysfunction (fecal incontinence, constipation syndromes) c. Other Current status of quality of life, awareness and knowledge, and care-seeking barriers among women with POP residing in Belagavi, India Inclusion
Criteria:
1.
All non-pregnant
women at the age of 15 married women (past & present) above consenting to
participate in the study.
Exclusion
Criteria:
1.
All pregnant
women.
Study
Site: Women attending the community served
by Primary Healthcare Centers (PHCs) managed by KAHER’s J N Medical College,
Belagavi.
Sample
size:
Estimated
sample size 467 in the Belagavi catchment area based on
prior prevalence data and pilot study. Methodology
1.
The study
participants who screen positive for POP screening tool, will be provided with the option to undergo
urogynecological examination by an obstetrics and gynecology resident, Urogynecology
fellow, or obstetrician and gynecologist in a mobile unit, and will be referred
for appropriate clinical management.
|